(95 days)
Advanced Neuromodulation Systems Spinal Cord Stimulation Leads are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The PLACER is intended to be used with ANS Trial Leads (percutaneous), ANS Permanent Quattrode® Leads, ANS Permanent Octrode® Leads, ANS Lamitrode S-Series Leads and peripheral nerve leads.
Not Found
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called PLACER™, an implanted spinal cord stimulator. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this letter does not contain details about:
- Specific acceptance criteria used in performance studies.
- The actual performance metrics of the device against any criteria.
- Information about sample sizes for test or training sets.
- Data provenance, expert qualifications, or adjudication methods for ground truth.
- Whether MRMC studies were conducted or the effect size of AI assistance.
- Standalone algorithm performance.
- The type of ground truth used.
All the requested study and performance-related details are absent from this regulatory clearance document.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).